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Draft guiding principles on human organ transplantation

Commentaries on the guiding principles

Commentary on the preamble

The purpose of this introductory proposition is to establish a comprehensive and exclusive system for the removal of organs from deceased and living donors for transplantation. As cadaver donation is best dealt with by national legislation, each jurisdiction will determine the definition of "deceased person" and criteria of death, as well as the means of implementing the Guiding Principles.

Commentary on guiding principle 1

There are two systems dealing with the obtaining of organs from deceased persons. These are (1) the "opting in"/"contracting in" ("explicit consent") system of post mortem organ removal, in which deceased persons expressly state before death that they approve such removal, or an appropriate family member expresses approval when the deceased person left no statement or other evidence to the contrary, and (2) the "opting out"/"contracting out" ("presumed consent") system. This presumes that organs may be removed for transplantation from the bodies of deceased persons unless those persons when alive stated their objections, or perhaps others who were close to them stated at an appropriate time that the persons objected to their deceased bodies being so treated. In the case of both the "opting in" and "opting out" systems, any statements or other adequate indications of opposition by persons to posthumous organ removal from their bodies will prevent such removal.

When a deceased person leaves no evidence of opposition to removal, the "opting in" system normally requires consent of an appropriate family member for organ removal. In the "opting out" system, no consent is required, but family members may take initiatives to state the opposition of the deceased person or of themselves.

Commentary on guiding principle 2

This provision is designed to reduce the possibility of a conflict of interest that would arise if the physician or physicians determining the death of a potential donor were also involved in organ removal or implantation.

Commentary on guiding principle 3

The first paragraph of this Principle is intended to emphasize the importance of developing cadaveric donation programmes in countries where this is culturally acceptable, and to discourage donations from living, genetically unrelated donors, except for transplantation of bone marrow and of other acceptable regenerative tissues.

The second paragraph seeks to protect potential donors from undue pressure and undue inducements from others. It emphasizes the necessity for complete and objective information to be given to the donor. It also takes into account issues relating to persons (other than minors) who are legally incompetent to fulfil the requirements for "free consent" or the other conditions specified in this paragraph.

Commentary on guiding principle 4

This Principle provides for absolute prohibition of the removal of organs for transplantation from legal minors. However, an exception concerning regenerative tissues may be allowed by national legislation. In such cases, the protection of minors could be assured by requiring, among other conditions, the minor's comprehending consent and the consent of the parent(s) or the legal guardian. The parent(s) or the legal guardian may have a conflict of interest, for example if they are responsible for the welfare of an intended recipient of the donated tissues. In such a case, prior permission of an independent body, such as a court or other appropriate authority of comparable independence or status should be required. However, an objection by the minor should take effect and prevail over any other consent.

Commentary on guiding principle 5

This Principle is designed to prohibit traffic in human organs for payment. The method of prohibition, including sanctions, will be determined independently by each jurisdiction. The Principle does not prohibit payment of reasonable expenses incurred in donation, recovery, preservation and supply of organs for transplantation.

Commentary on guiding principle 6

The intention of this Principle is to prohibit advertisements that have a commercial (profit-making) purpose. Promotion and encouragement of altruistic donation of human organs and tissues by means of advertisement or public appeal are not affected by this Principle.

Commentary on guiding principle 7

This provision deals with the involvement of physicians and other health professionals in removal, intermediate management and implantation of organs with knowledge, actual or constructive, that commercial transactions have occurred.

Commentary on guiding principle 8

This provision reinforces Guiding Principle 7 by restricting entrepreneurial practice in organ recovery and implantation. A medical or other health practitioner uncertain whether a fee proposed to be charged is justifiable may seek the opinion of an appropriate licensing or disciplinary authority before the fee is proposed or levied.